Photobiomodulation in the Treatment of Spasticity in Children With Cerebral Palsy. A Controlled, Randomized, Blind Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Cerebral palsy is a non-progressive, permanent syndrome that occurs in childhood and is accompanied by motor, tônus and posture disorders. Its etiology is related to an insult or damage to the central nervous system in maturation. Approximately 80% of cerebral palsy course with spasticity, which, when left untreated, will generate pain and functional, anatomical and structural changes, with a negative impact. Photobiomodulation therapy has biological effects of tissue regeneration, muscle relaxation, vasodilation, reduction of the inflammatory process and relief of pain symptoms already described in the literature, in addition to being feasible, practical, safe, without side effects, painless and non-invasive.This study is a blind, randomized and controlled clinical trial that will evaluate the effect of photobiomodulation in reducing gastrocnemius muscle spasticity in children aged 2 to 18 years, diagnosed with spastic cerebral palsy of lower limbs of any etiology for at least 03 months and randomized into two groups: application of Low Intensity LED Therapy in the medial and right lateral gastrocnemius muscles (device power of 100mW, wavelength of 850nm, energy of 3J/cm2/point, once a week, making 08 therapeutic days during 02 months) or placebo group Low-Intensity LED Therapy (same device turned off). Both groups will also receive the standard treatment for spasticity. To assess the response to therapy, the outcomes evaluated will be the modified Ashworth Scale, the Mobility Domain of Pediatric evaluation of disability inventory, the Gross Motor Function Classification System scale and passive and active range of motion of the ankle analyzed at the pré and post each therapeutic session and in the pre and post therapeutic period of 08 sessions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:

• Patients with diagnosis of spastic cerebral palsy affecting inferior limbs from any etiology;

• Cerebral palsy duration at least 03 months;

• Patients ongoing physiotherapy treatment at University.

Locations
Other Locations
Brazil
Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
RECRUITING
São Paulo
Universidade Nove de Julho / Post-Graduate program Biophotonics Applied to Health Sciences
RECRUITING
São Paulo
Contact Information
Primary
Rebeca B Cecatto
rebeca.boltes@gmail.com
11970842496
Time Frame
Start Date: 2023-08-15
Estimated Completion Date: 2026-02-20
Participants
Target number of participants: 28
Treatments
Experimental: Photobiomodulation (PBM) Treatment Group
Photobiomodulation therapy sessions will be carried out in the physiotherapy environment on the University, once a week, for 08 consecutive weeks in the same day of the institution's standard physiotherapy session that the patient already uses regularly (not linked to the study). will be transcutaneously, punctual application of the LED in the medial and lateral gastrocnemius muscles of the right lower limb, in contact mode, 3J/cm2, with a 850nm wavelenght (01 point per gastroc, muscle). All patients will received the PBM protocol + the standard physiotherapy rehabilitation treatment of the institute not linked to the study, and which the patient already uses regularly.
Placebo_comparator: Photobiomodulation (PBM) Placebo Group
PBM placebo therapy sessions will be carried out with the same characteristics of PBM treatment Group but with device turned off. All patients will received also the standard physiotherapy rehabilitation treatment of the institute not linked to the study, and which the patient already uses regularly.
Related Therapeutic Areas
Sponsors
Leads: University of Nove de Julho

This content was sourced from clinicaltrials.gov